Immunoassay for Neisseria gonorrhoeae antigens

Abstract

The present disclosure relates to a solid phase immunoassay for the detection of Neisseria gonorrhoeae antigens in a clinical specimen, wherein the Neisseria gonorrhoeae antigens to be determined are coated or adsorbed on the solid phase.

What is claimed is: 
     
       1. A method for determining Neisseria gonorrhoeae antigen in a clinical specimen comprising: (a) lysing Neisseria gonorrhoeae cells in the specimen to release Neisseria gonorrhoeae antigen;   (b) coating a bare solid support with the Neisseria gonorrhoeae antigen;   (c) separating the antigen coated solid support from the specimen;   (d) treating the antigen coated solid support with gonococcal antibody to form antigen-gonococcal antibody complex on the solid support;   (e) separating the antigen-gonococcal antibody complex from unbound gonococcal antibody;   (f) treating the antigen-gonococcal antibody complex with labeled antiglobulin, to form an antigen-gonococcal antibody-labeled antiglobulin complex on the solid support;   (g) separating the antigen-gonococcal antibody-labeled antiglobulin complex from unbound labeled antiglobulin; and   (h) determining the labeled antiglobulin bound to the antigen-gonococcal antibody complex as a measure of the Neisseria gonorrhoeae antigen in the specimen.   
     
     
       2. A method according to claim 1 wherein the Neisseria gonorrhoeae cells are lysed using a buffered saline solution and a surfactant. 
     
     
       3. A method according to claim 2 wherein the surfactant is a deoxycholate salt. 
     
     
       4. A method according to claim 3 wherein the deoxycholate salt is sodium deoxycholate. 
     
     
       5. A method according to claim 1 wherein the gonococcal antibody is produced by immunizing an animal with a pool of Neisseria gonorrhoeae strains. 
     
     
       6. A method according to claim 1 wherein the antiglobulin is labeled with an enzyme. 
     
     
       7. A method according to claim 1 wherein the separation steps are performed by aspiration and washing with water. 
     
     
       8. A method for determining Neisseria gonorrhoeae antigen in a clinical specimen comprising: (a) lysing Neisseria gonorrhoeae cells in the specimen to release Neisseria gonorrhoeae antigen;   (b) coating a bare solid support with the Neisseria gonorrhoeae antigen;   (c) separating the antigen coated solid support from the specimen;   (d) treating the antigen coated solid support with gonococcal antibody to form an antigen-gonococcal antibody complex on the solid support;   (e) separating the antigen-gonococcal antibody complex from unbound gonococcal antibody;   (f) treating the antigen-gonococcal antibody complex with antiglobulin, to form an antigen-gonococcal antibody-antiglobulin complex on the solid support;   (g) separating the antigen-gonococcal antibody-antiglobulin complex from unbound antiglobulin;   (h) treating the antigen-gonococcal antibody-antiglobulin complex with labeled antibody to the antiglobulin to form an antigen-gonococcal antibody-antiglobulin-labeled antibody complex on the solid support;   (i) separating the antigen-gonococcal antibody-antigloblin-labeled antibody complex from unbound labeled antibody; and   (j) determining the labeled antibody bound to the antigen-gonococcal antibody-antiglobulin complex as a measure of the Neisseria gonorrhoeae antigen in the specimen.   
     
     
       9. A method according to claim 8 wherein the Neisseria gonorrhoeae cells are lysed using a buffered saline solution and a surfactant. 
     
     
       10. A method according to claim 9 wherein the surfactant is a deoxycholate salt. 
     
     
       11. A method according to claim 10 wherein the deoxycholate salt is sodium deoxycholate. 
     
     
       12. A method according to claim 8 wherein the gonococcal antibody is produced by immunizing an animal with a pool of Neisseria gonorrhoeae strains. 
     
     
       13. A method according to claim 8 wherein the antiglobulin is labeled with an enzyme. 
     
     
       14. A method according to claim 8 wherein the separation steps are performed by aspiration and washing with water. 
     
     
       15. A method for determining Neisseria gonorrhoeae antigen in a clinical speciman comprising: (a) lysing Neisseria gonorrhoeae cells in the specimen to release Neisseria gonorrhoeae antigen;   (b) coating the bare solid support with the Neisseria gonorrhoeae antigen;   (c) separating the antigen coated solid support from the specimen;   (d) treating the antigen coated solid support with labeled gonococcal antibody;   (e) separating the antigen coated solid support treated with labeled gonococcal antibody from unbound labeled gonococcal antibody; and   (f) determining the labeled gonococcal antibody bound to the antigen coated solid support as a measure of the Neisseria gonorrhoeae antigen in the specimen.